Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Institute on Aging (NIA)
Study ID
NCT03852901
Phase
PHASE1
Status
Completed

Conditions

  • Empaglifozin
  • Hypoglycemic Agents
  • Physiological Effects of Drugs
  • Sodium-Glucose Transporter 2 Inhibitors

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Background: The drug empagliflozin treats diabetes. It lowers blood sugar by increasing glucose the kidneys excrete. This increases levels of ketones formed in the blood. The body makes ketones when it does not have enough glucose for fuel. The brains of many people with age-related diseases like Alzheimer's do not use glucose well. Brain use of ketones might improve mental ability. We investigated how empagliflozin affects ketone levels, which could lead to ways to improve brain health as people age. Objectives: To study how taking empagliflozin affects systemic and brain metabolism including ketone levels in people without diabetes. Eligibility: Adults at least 55 years old without diabetes Design: After a screening Visit, eligible participants were admitted to the NIA Clinical Unit during Visits 1 (baseline), 2 (first dose) and 3 (last/14th dose). On each Visit, blood draws were performed and circulating metabolites and hormones were repeatedly measured over 34-hour periods. Using plasma from fasting state only, we isolated total and neuronal-origin extracellular vesicles to measure proteins of the IGF-1 and insulin signaling cascades. Furthermore, on each Visit, we performed magnetic resonance spectroscopy (MRS) to measure concentrations of a plethora of metabolites in the brain. Between Visits 2 and 3, participants were taking the drug at home. A continuous glucose monitoring device was placed to detect potential glucose fluctuations while at home. The study was concluded for participants after the end of Visit 3.

Key Dates

Start date
Mar 28, 2019
Status verified
Dec 2021
Primary completion
Nov 12, 2020
Completion
Dec 13, 2021

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Single Arm
    Single group

Primary Outcome Measure

Change in Serum β-hydroxybutyrate (BHB) [ Time Frame: 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institute on Aging, Clinical Research UnitBaltimoreMaryland21224-

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